- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02160587
Safety Study to Evaluate the Contact Sensitizing Potential of Topically Applied ZuraPrep™ and ZuraPrep™ Without IPA
March 11, 2015 updated by: Zurex Pharma, Inc.
A Clinical Evaluation of the Contact Sensitizing Potential of Topically Applied ZuraPrep™ and ZuraPrep™ Without IPA in Healthy Adult Volunteers
This is a safety study to determine the skin sensitization potential of ZuraPrep™ and ZuraPrep™ without isopropyl alcohol (IPA) after repetitive patch applications to skin of human subjects.
Indications of both sensitization and skin irritation will be evaluated.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study is designed to determine if the test product, ZuraPrep™ is a skin sensitizing agent when applied to human skin.
The study, a modified Draize skin sensitization evaluation, will be conducted in three discrete phases: 1) induction, 2) rest, and 3) challenge.
During the Induction Phase, skin sites are exposed to the test product repeatedly for 21 consecutive days.
The Rest Phase, a 14-day period when no treatment is performed, serves to provide adequate time for the immune system to react to ZuraPrep™, given any of its components serve as antigens.
During the Challenge Phase, the subjects' skin is re-exposed to the test product (ZuraPrep™) to determine if it is likely to be immunosensitizing.
Study Type
Interventional
Enrollment (Actual)
208
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Montana
-
Bozeman, Montana, United States, 59718
- BioScience Laboratories, Inc.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subjects may be of either sex, at least 18 years of age and of any race
- Subjects must be free of tattoos, sunburn, dermatoses, cuts, lesions or other disorders of the skin of the back.
- Subjects must be in good general health
Exclusion Criteria:
- Known allergies to latex, metals, tape and/or adhesives, soap, citric acid, methylene blue, methylparaben, propylparaben, chlorhexidine gluconate, isopropyl alcohol, and sodium lauryl sulfate.
- Exposure of the back region to antimicrobial agents, medicated soaps, medicated shampoos, medicated lotions, strong detergents, sun-tanning, use of tanning beds, or swimming or soaking in pools or hot tubs, in the 7 days prior to, or during the 3-week test period.
- Use of topical or systemic corticosteroid, antihistamine, or anti-inflammatory medications in the 7 days prior to, or during the 3-week test period.
- Current or recent severe illness such as asthma, diabetes, hepatitis, organ transplant, mitral valve prolapse, congenital heart disease, internal prostheses, or any immunocompromised condition such as AIDS or HIV positive.
- Pregnancy, plans to become pregnant, breast-feeding
- Any active skin rash or breaks in the skin of the back
- Any sunburn or tattoos on the skin of the back
- Current active skin disease or inflammatory skin condition including contact dermatitis
- Participation in a clinical study in the past 7 days or current participation in another clinical study
- Any medical condition or use of any medications that, in the opinion of the Principal Investigator, would preclude participation
- Unwillingness to fulfill the performance requirements of the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: ZuraPrep
Irritation scores of the following applied to test sites will be compared: ZuraPrep, ZuraPrep without IPA, ChloraPrep, and 0.9% Physiological Saline.
|
ChloraPrep will be compared to ZuraPrep with regard to skin sensitization and irritation.
Other Names:
0.9% Physiological Saline will be compared to ZuraPrep with regard to skin sensitization and irritation.
Other Names:
ZuraPrep without IPA will be compared to ZuraPrep with regard to skin sensitization and irritation
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Skin sites evaluated and graded for irritancy or sensitization
Time Frame: 0-40 days post dose
|
Only frank sensitization will be categorized, as a positive control (known sensitizing agent) is prohibitive due to ethical considerations/risk of life-time sensitization.
Reactions observed will be assessed as to whether indicative of sensitization or of irritation.
|
0-40 days post dose
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Statistics of irritation scores
Time Frame: 0-40 days post dose
|
Irritation scores, relative to the Test Products, Reference Product, and the Negative Control applied to skin on each test day will be compared as well as the total cumulative irritation scores across all test days.
|
0-40 days post dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Maggie Butler, PhD, BioScience Laboratories, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2014
Primary Completion (Actual)
October 1, 2014
Study Completion (Actual)
October 1, 2014
Study Registration Dates
First Submitted
June 5, 2014
First Submitted That Met QC Criteria
June 6, 2014
First Posted (Estimate)
June 10, 2014
Study Record Updates
Last Update Posted (Estimate)
March 17, 2015
Last Update Submitted That Met QC Criteria
March 11, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 130821-303 (ZX-ZP-0018)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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